Type 1 DiabetesNCT07471906
Compliance to Vaccination in Children With Diabetes and Their Siblings
An observational study of Type 1 Diabetes, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
This is an observational, single-center, cross-sectional study about adherence to both obligatory and recommended vaccination in children with Type 1 Diabetes Mellitus and their siblings. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Compliance to vaccination schedule
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 1 Nov 2019to 15 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Parents or legal-caregivers of children diagnosed with Type 1 Diabetes Mellitus will be asked to provide information regarding the vaccination status of their children (date of performed vaccinations)
Who may be able to join
- Willingness to participate in the study
- Informed consent obtained by parents or legal caregivers before any trial-related activities.
- Documented diagnosis of tyoe 1 Diabetes mellitus in one children of the family
- Written documents on vaccination schedules in participating subjects (children with Type 1 Diabetes and siblings)
Who cannot join
- 1. Communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compliance to Obligatory and Recommended Vaccination in Children With Type 1 Diabetes Mellitus and Their Siblings
This is an observational, single-center, cross-sectional study about adherence to both obligatory and recommended vaccination in children with Type 1 Diabetes Mellitus and their siblings.
Read the detailed description
A great amount of discussion has been made regarding the possible association between routine vaccinations and the risk of childhood type 1 diabetes mellitus. This study is designed to explore the level of compliance to obligatory and recommended vaccinations in children after being diagnosed with Type 1 Diabetes Mellitus and their siblings.
- Conditions
- Type 1 Diabetes
- Being tested
- Compliance to vaccination schedule
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compliance to vaccination scheduleBehavioural
Record the percentage of performed vaccination / required vaccination
| Study group | Role | What they receive |
|---|---|---|
| Children with type 1 Diabetes | Retrospective analysis of their vaccination program Receives: Behavioral: Compliance to vaccination schedule | |
| Siblings of children with Typw 1 Diabetes | Retrospective analysis of their vaccination program Receives: Behavioral: Compliance to vaccination schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time in Range (TIR) in children with T1D after switching to ultra-rapid insulin aspart
Percentage of time that interstitial glucose levels are between 70-180 mg/dL, measured using continuous or intermittent flash glucose monitoring (CGM or FreeStyle Libre®).
Measured: 3-6 months after insulin switch
Secondary outcomes (4)
Change in Time Above Range (TAR) after switching to ultra-rapid insulin aspart
Percentage of time that interstitial glucose levels are above 180 mg/dL, measured using continuous or intermittent flash glucose monitoring (CGM or FreeStyle Libre®).
Measured: 3-6 months after switching insulin
Change in Glycated Hemoglobin (A1c) after switching to ultra-rapid insulin aspart
Mean HbA1c (%) calculated from laboratory measurements over the 12 months before and after insulin switch
Measured: 12 months
Change in Time Below Range (TBR) after switching to ultra-rapid insulin aspart
Percentage of time that interstitial glucose levels are below 70 mg/dL, measured using continuous or intermittent flash glucose monitoring (CGM or FreeStyle Libre®).
Measured: 3-6 months after switching insulin
Change in total daily insulin dose and basal/bolus proportions
Total daily insulin (U/kg/day) and percentage of basal and bolus insulin, obtained from clinical records before and after switching to ultra-rapid insulin aspart.
Measured: 3-6 months after switching insulin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Nov 2019
- Primary completion30 Nov 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athanasios Christoforidis, Aristotle University Of Thessaloniki
- Investigators
- Athanasios Christoforidis, PhD, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471906
- Sponsor's protocol ID
- AUTH-AC-2
- Status last verified
- Mar 2026
- First submitted
- 26 Oct 2019
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance to Obligatory and Recommended Vaccination in Children With Type 1 Diabetes Mellitus and Their Siblings
- ClinicalTrials.gov ID
- NCT07471906
- Acronym / sponsor ID
- AUTH-AC-2
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational, single-center, cross-sectional study about adherence to both obligatory and recommended vaccination in children with Type 1 Diabetes Mellitus and their siblings.
Detailed description
A great amount of discussion has been made regarding the possible association between routine vaccinations and the risk of childhood type 1 diabetes mellitus. This study is designed to explore the level of compliance to obligatory and recommended vaccinations in children after being diagnosed with Type 1 Diabetes Mellitus and their siblings.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with type 1 Diabetes | – | Behavioral: Compliance to vaccination scheduleRetrospective analysis of their vaccination program |
| Siblings of children with Typw 1 Diabetes | – | Behavioral: Compliance to vaccination scheduleRetrospective analysis of their vaccination program |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Parents or legal-caregivers of children diagnosed with Type 1 Diabetes Mellitus will be asked to provide information regarding the vaccination status of their children (date of performed vaccinations)
Key inclusion criteria (4 listed)
- Willingness to participate in the study
- Informed consent obtained by parents or legal caregivers before any trial-related activities.
- Documented diagnosis of tyoe 1 Diabetes mellitus in one children of the family
- Written documents on vaccination schedules in participating subjects (children with Type 1 Diabetes and siblings)
Key exclusion criteria (1 listed)
- 1. Communication problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compliance to vaccination scheduleRecord the percentage of performed vaccination / required vaccination | Behavioural | Children with type 1 Diabetes, Siblings of children with Typw 1 Diabetes |
Primary outcome
Change in Time in Range (TIR) in children with T1D after switching to ultra-rapid insulin aspart
Time frame: 3-6 months after insulin switch
Percentage of time that interstitial glucose levels are between 70-180 mg/dL, measured using continuous or intermittent flash glucose monitoring (CGM or FreeStyle Libre®).
4 secondary outcomes
Change in Time Above Range (TAR) after switching to ultra-rapid insulin aspart
Time frame: 3-6 months after switching insulin
Change in Glycated Hemoglobin (A1c) after switching to ultra-rapid insulin aspart
Time frame: 12 months
Change in Time Below Range (TBR) after switching to ultra-rapid insulin aspart
Time frame: 3-6 months after switching insulin
Change in total daily insulin dose and basal/bolus proportions
Time frame: 3-6 months after switching insulin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanasios Christoforidis, PhD principal investigator
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Time in Range (TIR) in children with T1D after switching to ultra-rapid insulin aspart (time frame: 3-6 months after insulin switch). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.